CA2473975A1 - Glucan based film delivery systems - Google Patents

Glucan based film delivery systems Download PDF

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Publication number
CA2473975A1
CA2473975A1 CA002473975A CA2473975A CA2473975A1 CA 2473975 A1 CA2473975 A1 CA 2473975A1 CA 002473975 A CA002473975 A CA 002473975A CA 2473975 A CA2473975 A CA 2473975A CA 2473975 A1 CA2473975 A1 CA 2473975A1
Authority
CA
Canada
Prior art keywords
water
delivery system
soluble
film
ingestible
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002473975A
Other languages
French (fr)
Other versions
CA2473975C (en
Inventor
Robert K. Yang
Richard C. Fuisz
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Aquestive Therapeutics Inc
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US10/074,272 external-priority patent/US7425292B2/en
Application filed by Individual filed Critical Individual
Publication of CA2473975A1 publication Critical patent/CA2473975A1/en
Application granted granted Critical
Publication of CA2473975C publication Critical patent/CA2473975C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7015—Drug-containing film-forming compositions, e.g. spray-on
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7007—Drug-containing films, membranes or sheets
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F26—DRYING
    • F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
    • F26B13/00—Machines and apparatus for drying fabrics, fibres, yarns, or other materials in long lengths, with progressive movement
    • F26B13/10—Arrangements for feeding, heating or supporting materials; Controlling movement, tension or position of materials
    • F26B13/101—Supporting materials without tension, e.g. on or between foraminous belts
    • F26B13/104—Supporting materials without tension, e.g. on or between foraminous belts supported by fluid jets only; Fluid blowing arrangements for flotation dryers, e.g. coanda nozzles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin

Abstract

An ingestible water-soluble delivery system in the form of a film composition comprising a glucan and a water-soluble polymer, wherein the ratio of glucan to water soluble polymer is about 40:1 to about 0.1:5. Delivery system films of the present invention include a low content of pullulan and can include a relatively high content of a pharmaceutical, cosmetic, or biologically-active agent.

Claims (36)

1. An ingestible water-soluble delivery system in the form of a film composition comprising a glucan and a water-soluble polymer, wherein the ratio of glucan to water soluble polymer is about 40:1 to about 0.1:5.
2. The ingestible water-soluble delivery system of claim 1, wherein the ratio is about 10:1 to about 1:5.
3. The ingestible water-soluble delivery system of claim 1, wherein said glucan is selected from the group consisting of pullulan, elsinan and combinations thereof.
4. The ingestible water-soluble delivery system of claim 1, wherein said water-soluble polymer is a cellulosic material, a gmn, a protein, a starch, and combinations thereof.
5. The ingestible water-soluble delivery system of claim 1, wherein said water-soluble polymer is selected from the group consisting of carboxymethyl cellulose, hydroxyl methyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose hydroxypropylmethyl cellulose, and combinations thereof.
6. The ingestible water-soluble delivery system of claim 1, wherein said water-soluble polymer is selected from the group consisting of gum arabic, xanthan gum, tragacanth, acacia, carageenan, guar gum, locust bean gum, pectin, alginates and combinations thereof.
7. The ingestible water-soluble delivery system of claim 1, wherein said water-soluble polymer is selected from the group consisting of polyvinyl alcohol, polyacrylic acid, polyvinyl pyrrolidone, poly(meth)acrylate, poly(meth)copolymers and combinations thereof.
8. The ingestible water-soluble delivery system of claim 1, wherein said water-soluble polymer is a starch selected from the group consisting of tapioca, rice, corn, potato, wheat and combinations thereof.
9. The ingestible water-soluble delivery system of claim 8, wherein said starch is gelatinized, modified or unmodified.
10. The ingestible water-soluble delivery system of claim 1, wherein said water-soluble polymer is a protein selected from the group consisting of gelatin, zero, gluten, soy protein, soy protein isolate, whey protein, whey protein isolate, casein, levin, collagen and combinations thereof.
11. The ingestible water-soluble delivery system of claim 1, wherein said water-soluble polymer is selected from the group consisting of dextrin, dextran and combinations thereof.
12. The ingestible water-soluble delivery system of claim 1, wherein said water-soluble polymer is selected from the group consisting of chitin, chitosin or combinations thereof.
13. The ingestible water-soluble delivery system of claim 1, wherein said water-soluble polymer is polydextrose.
14. The ingestible water-soluble delivery system of claim 1, wherein said water-soluble polymer is selected from the group consisting of dextrin, dextran and combinations thereof.
15. The ingestible water-soluble delivery system of claim 1, further comprising an active component selected from the group consisting of cosmetic agents, pharmaceutical agents, bioactive agents and combinations thereof.
16. The ingestible water-soluble delivery system of claim 1, wherein said active component is present in amounts of up to about 60% by weight of the total composition.
17. The ingestible water-soluble delivery system of claim 1, wherein said active component is present in amounts of up to about 0.1% to about 60% by weight of the total composition.
18. The ingestible water-soluble delivery system of claim 1, further comprising one or more members selected from the group consisting of taste-masking agents, plasticizing agents, surfactants, emulsifying agents, thickening agents, binding agents, cooling agents, saliva-stimulating agents, sweetening agents, antimicrobial agents and combinations thereof.
19. A dried film formed from the composition of claim 1.
20. A dried film formed from the composition of claim 15.
21. A dried film formed from the composition of claims 1 or 15 having a thickness up to about 5mm.
22. The dried film of claims 19 or 20 having a polymeric carrier backing.
23. The dried film of claims 19 or 20 in unit dosage form sealed in a pouch.
24. A pharmaceutical and/or cosmetic dosage form comprising an ingestible water-soluble film composition comprising a glucan and a water-soluble polymer, wherein the ratio of glucan to water soluble polymer is about 40:1 to about 0.1:5 having no more than a 10%
variance of a pharmaceutical and/or cosmetic active per unit area.
25. A pharmaceutical and/or cosmetic dosage form comprising a film having a uniformly dispersed composition comprising a glucan and a water-soluble polymer, a pharmaceutical and/or cosmetic active and a solvent, said film being formed by depositing a wet film of said composition onto a substrate surface and controllably drying the wet film from the side contacting the substrate to prevent self aggregation and achieve compositional uniformity.
26. A pharmaceutical composition in the form of a film for enteral or topical administration, comprising a composition having a uniformly distributed combination of a glucan, a water-soluble polymer, a polar solvent, and a pharmaceutical active, wherein said glucan and said~water-soluble polymer are present in a ratio of about 40:1 to about 0.1:5, said composition in its dried film form maintaining the uniform distribution of components through the application of controlled bottom drying of the film.
27. The ingestible water-soluble delivery system of claim 15, wherein said pharmaceutical active is selected from the group consisting of antimicrobial agents, non-steroidal anti-inflammatory drugs, anti-tussives, decongestants, antihistamines, expectorants, anti-diarrheals, Ha antagonists, proton pump inhibitors, general non-selective CNS
depressants, general non-selective CNS stimulants, selective CNS functional modifiers, anti-parkinsonism drugs, narcotics, analgesics, anti-pyretics, psychopharmacological drugs and combinations thereof.
28. The ingestible water-soluble delivery system of claim 1, wherein the film composition is essentially free of a surfactant.
29. The ingestible water-soluble delivery system of claims 1 or 28, wherein the film composition is essentially free of a plasticizer.
30. The ingestible water-soluble delivery system of claims 1, 28 or 29, wherein the film composition is essentially free of a polyalcohol.
31. The pharmaceutical and/or cosmetic dosage form of claims 24 or 25 , wherein the film is essentially free of a surfactant.
32. The pharmaceutical and/or cosmetic dosage form of claims 24, 25, or 31, wherein the film is essentially free of a plasticizer.
33. The pharmaceutical and/or cosmetic dosage form of claims 24, 25, 31 or 32, wherein the film is essentially free of a polyalcohol.
34. The pharmaceutical composition of claim 26, wherein the film is essentially free of a surfactant.
35. The pharmaceutical composition of claims 26 or 34, wherein the film is essentially free of a plasticizer.
36. The pharmaceutical composition of claims 26, 34 or 35, wherein the film is essentially free of a polyalcohol.
CA2473975A 2001-10-12 2002-10-11 Glucan based film delivery systems Expired - Lifetime CA2473975C (en)

Applications Claiming Priority (9)

Application Number Priority Date Filing Date Title
US32886801P 2001-10-12 2001-10-12
US60/328,868 2001-10-12
US10/074,272 2002-02-14
US10/074,272 US7425292B2 (en) 2001-10-12 2002-02-14 Thin film with non-self-aggregating uniform heterogeneity and drug delivery systems made therefrom
US37194002P 2002-04-11 2002-04-11
US60/371,940 2002-04-11
US38693702P 2002-06-07 2002-06-07
US60/386,937 2002-06-07
PCT/US2002/032542 WO2003030881A1 (en) 2001-10-12 2002-10-11 Glucan based film delivery systems

Publications (2)

Publication Number Publication Date
CA2473975A1 true CA2473975A1 (en) 2003-04-17
CA2473975C CA2473975C (en) 2011-05-03

Family

ID=27491110

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2473975A Expired - Lifetime CA2473975C (en) 2001-10-12 2002-10-11 Glucan based film delivery systems

Country Status (6)

Country Link
EP (1) EP1463490B1 (en)
JP (1) JP4795639B2 (en)
AT (1) ATE536869T1 (en)
AU (2) AU2002332118B2 (en)
CA (1) CA2473975C (en)
WO (1) WO2003030881A1 (en)

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Also Published As

Publication number Publication date
AU2008227076A1 (en) 2008-10-16
EP1463490B1 (en) 2011-12-14
JP4795639B2 (en) 2011-10-19
EP1463490A1 (en) 2004-10-06
AU2002332118B2 (en) 2008-06-26
CA2473975C (en) 2011-05-03
JP2005528328A (en) 2005-09-22
WO2003030881A1 (en) 2003-04-17
ATE536869T1 (en) 2011-12-15

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Effective date: 20221011